Recall Z-1187-03 ยท MIE Heart-Valve, Allograft
Cryolife Inc
Heart-valve, allograft
| Date | Aug 28, 2003 (initiated Feb 4, 2003) |
| Status | Terminated |
| Reason | Donor of aortic valve had procurement cultures that were positive for E-coli. |
| Root cause | Other |
| Action | A CryoLife representative contacted the consignee by telephone on 2/4/2002 to inform her of the recall action. The graft was returned to CryoLife and destroyed on/about 2/11/2003. |
| Quantity | 1 unit |
| Distribution | Allograft was distrbuted to one medical facility in CA. No government or foreign accounts involved. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.